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The Soteira Shield Kyphoplasty System (SKS) is intended to provide control of cement flow during injection of PMMA bone cement that has been cleared for use in vertebral augmentation for the treatment of acute, persistently painful (after a minimum of 6 weeks of conservative care), stable, anterior column osteoporotic compression fractures (wedge or concave) of the vertebrae at levels T4 - L5 in the adult spine.

The Soteira Shield Kyphoplasty System consists of a cement director (permanent implant), a delivery system (used to place the cement director within the vertebral body) and instruments that are used to achieve percutaneous access to the vertebral body and to create a cavity into which the cement director implant will be placed. The system is intended for use with commercially available PMMA bone cement.

The provided text describes a 510(k) premarket notification for the Soteira Shield Kyphoplasty System, a device for vertebral augmentation. The information focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria with specific acceptance thresholds for device performance.

Therefore, the concept of "acceptance criteria" as applied to a new AI/software device with quantitative performance metrics (e.g., accuracy, sensitivity, specificity) and a "reported device performance" against those criteria is not directly applicable here. The equivalence is demonstrated through comparative studies against established predicate devices.

However, based on the provided text, we can infer the "acceptance criteria" and "reported device performance" in terms of how the Soteira Shield Kyphoplasty System compares to its chosen predicate device (vertebroplasty) across various aspects.

Here's an interpretation of the request using the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" for a 510(k) submission are typically centered around demonstrating substantial equivalence to legally marketed predicate devices. This means showing that the new device is as safe and effective as the predicate. Quantifiable performance metrics against predefined thresholds, as seen in AI/software device evaluations, are not explicitly stated. Instead, the performance is assessed relative to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The clinical study served as the primary "test set" for equivalence demonstration.

• Sample Size for Test Set:
  • Soteira Shield Kyphoplasty System: 69 subjects and 102 levels.
  • Control Device (Vertebroplasty): 28 subjects and 38 levels.
• Data Provenance: The study was a "prospective randomized study." The country of origin is not specified but implicitly within the US regulatory context (indicated by FDA 510(k) submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The text does not mention the use of experts to establish a "ground truth" in the diagnostic sense, as this is a medical device for treatment. The "ground truth" for the clinical study would be derived from clinical outcomes, patient-reported pain scores, functional assessments, and imaging assessments of cement leakage. The study's design (prospective, randomized) implies that standard clinical methodologies and assessments were used, likely carried out by treating physicians and study staff, but specific numbers and qualifications of "experts" for ground truth establishment are not provided.

4. Adjudication Method for the Test Set

The text does not explicitly describe an adjudication method for the test set data. In a prospective clinical trial like this, data collection and assessment would follow a pre-defined protocol, and outcomes (pain, function, adverse events, leakage) would be recorded. Any discrepancies in data recording or interpretation would typically be handled through standard clinical trial monitoring and data management processes, but a specific "adjudication method" beyond standard clinical practice is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This is not applicable. The study is for a physical medical device (Kyphoplasty System) for treating vertebral fractures, not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a surgical system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was based on:

• Clinical Outcomes: Patient-reported pain levels, functional scores, and recorded adverse events.
• Imaging Data: Assessment of cement leakage.
• Medical Diagnosis: Diagnosis of osteoporotic compression fractures requiring intervention.

8. The Sample Size for the Training Set

This is not applicable. The Soteira Shield Kyphoplasty System is a physical medical device, not a machine learning algorithm that requires a "training set" in the computational sense. The "pilot study" mentioned could be considered an early phase of clinical data collection that might inform the design of the larger prospective study, but it doesn't function as a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no "training set" in the context of an algorithmic device.

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